EARACHE RELIEF- apis mellifera, arnica montana, atropa belladonna, tribasic calcium phosphate, echinacea, unspecified, calcium sulfide, mercurius solubilis tablet, orally disintegrating

EarAche Relief by

Drug Labeling and Warnings

EarAche Relief by is a Homeopathic medication manufactured, distributed, or labeled by TRP Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Apis mellifica HPUS - 6x, 12x, 18x

Arnica montana HPUS - 6x, 12x, 18x

Belladonna HPUS - 6x, 12x, 18x

Calcarea phosphorica HPUS - 6x, 12x, 18x

Echinacea HPUS - 3x

Hepar sulphuris calcareum HPUS - 6x, 12x, 18x

Mercurius solubilis HPUS - 6x, 12x, 18x

HPUS indicates the active ingredients are in the Homeopathic Pharmacopoeia of the United States.

PURPOSE

Apis mellifica HPUS - Discomfort, Redness of external ear

Arnica montana - Bruised sensation in external ears

Belladonna HPUS - Fullness, Congestion

Calcarea phosphorica HPUS - Itching, Coldness, Irritability

Echinacea HPUS - Immune support

Hepar sulphuris calcareum HPUS - Sensitivity to water, wind, cold and touch

Mercurius solubilis - Swimmer’s ear irritation

Uses

Warnings

USE ONLY AFTER DIAGNOSIS BY A PHYSICIAN AND UNDER THE SUPERVISION OF A PHYSICIAN.

This product is intended to complement, not replace, standard medical treatment.

• Initial worsening of symptoms may occur.
• A physician should always be consulted to rule out serious causes.
• In case of overdose, get medical help or contact a Poison Control Center right away.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

Directions

• Suitable for adults and children 12 years and above.
• Dissolve entire tablet under tongue.
• Do not chew or swallow whole.
• Take 1 tablet 3 times a day or as directed by a physician.
• Use up to 6 times a day as needed.
• Take at least 10 minutes before or at least 10 minutes after eating or drinking.
• Children under the age of 12: consult a physician before use.
• Homeopathic remedies may not be effective for everyone.

Other information

• There are no known contraindications.
• Active ingredients are micro-diluted in accordance with the Homeopathic Pharmacopoeia of the United States and are therefore non-toxic with no known side effects.
• Store in a cool dark location.
• EarAche Relief Fast Dissolving Tablets are homeopathic dilutions: see www.thereliefproducts.com for details.

Inactive Ingredients

Advantol® 300, Lactose, Magnesium Stearate, Mannitol, Microcrystalline Cellulose.

Do not use if tamper evident seal is torn, broken or missing.

QUESTIONS

Questions or comments? www.thereliefproducts.com, 888-969-6855

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EARACHE RELIEF 
apis mellifera, arnica montana, atropa belladonna, tribasic calcium phosphate, echinacea, unspecified, calcium sulfide, mercurius solubilis tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17312-025
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	6 [hp_X]
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	6 [hp_X]
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	6 [hp_X]
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	6 [hp_X]
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX)	ECHINACEA, UNSPECIFIED	3 [hp_X]
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	6 [hp_X]
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2)	MERCURIUS SOLUBILIS	6 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
MANNITOL (UNII: 3OWL53L36A)
SORBITOL (UNII: 506T60A25R)
CROSPOVIDONE (UNII: 68401960MK)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
COPOVIDONE (UNII: D9C330MD8B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	no score
Shape	DIAMOND	Size	13mm
Flavor		Imprint Code	TRP
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17312-025-14	1 in 1 PACKAGE	04/28/2015
1		70 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/05/2013

Labeler - TRP Company (105185719)